Overview The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs.
Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands. We are seeking a skilled and experiencedQA Validation Specialist to join a Client Validation team.
This role will be responsible for the review and approval of validation lifecycle activities in a GMP regulated environment, focused on implementation of new manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment. Responsibilities Provide project management oversight from a Quality perspective for FUE activities related to products and facilities, utilities, equipment (FUE)Assist Functional Validation groups in the development of validation plans for specific system implementation projectsReview and Approval of project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutionsEstablish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP'sMaintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by the client, validation techniques/approaches and systems utilized at the client siteLead and represent Validation in multi-departmental meetings & project teamsIdentify and implement improvements to the QA Validation systemsParticipation in the change control program for NPIs, capital projects and modifications to qualified systemsEnsure maintenance of the qualified/validated state within the Revalidation Evaluation and Requalification programmesReview and Approval of validation activities and documentation related to maintenance of qualified / validated statesAssess the impact of changes to the validated state of systems/equipment as part of the site change control program (e.g.
system implementation projects /system modifications, etc.)
and QMS deviations.
Demonstrate a robust understanding of Change Control process, appreciating wider implications to site beyond immediate requirementIdentify, track and resolve issues through robust root cause analysis in a timely manner working with relevant SMEs as required.
Apply a risk management approach to identify, categorise, prioritise, mitigate and establish contingency plans associated with qualification / validation and system risksCoordinate validation activities involving cross-functional, multi-departmental teams including: Engineering, Manufacturing, Process Sciences, Quality Control, Quality Assurance, Regulatory Affairs, and others. Qualifications Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required+5 years' experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validationOrganizational and management skills to coordinate multi-discipline project groupAbility to speak, present data, and defend approaches in front of audiences and inspectorsAbility to comprehend technical information related to equipment, processes, and regulatory expectationsExperience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspectionsUnderstanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectationsProficiency with technical summary report review and approval required, with exceptional organizational, spelling, grammar, and typing skills preferred.#LI-AM2
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